October 2009

• Policy OHSR.2 Organization Policy on JHM Response to Sponsor Requests for Economic Data

August 2009

• Significant Differences between FDA and DHHS Regulations
• Policy D403 Organization Policy on Research Involving Children
• Plans for Detecting and Managing Incidental Findings Associated with Research Imaging Procedures

• Policy OHSR.1 Organization Policy on Incidental Findings Associated with Research Imaging Procedures

July 2009

• Policy 111.8 Organization Policy on Research Involving Vulnerable Populations
• Fees for JHM IRB and WIRB Review of Research Protocols

June 2009

• Research Projects Involving Social Services Administration of the State of Maryland Department of Human Resources Department of Social Services (Foster Children)
• DSS Submission Form
• Application of GCP to the Conduct of Clinical Research at JHM
• Sample GCP Checklist

February 2009

• HIPAA Form 3 "Authorization to Contact You About Future Research Studies"
• HIPAA Form 4 "Application for IRB Waiver of HIPAA Privacy Authorization"

January 2009

• Training Requirements
• JHH Nursing Research Approval
• School of Nursing Requirements
• Monitoring Program
• Oncology Research

November 2008

• Investigator Responsibilities Guidance
• Record Retention
• State of Maryland Law and Consent for HIV Testing
• Policy No. ORA.3 Organization Policy on Tobacco Company Funding
  

October 2008

• Clinical Engineering Services and Human Subjects Research Activities

September 2008

• ICTR Introduces Research Ethics Consulting Service
• Policy No. ORA.2 Organization Policy on Prospective Reimbursement Analysis

August 2008

• Policy B203 Organization Policy on Research Involving Pregnant Women, Fetuses, Neonates

June 2008

• Guidance - Training Requirements for Human Subjects Research
• Guidance - Registration of Clinical Trials
• Policy 115.2 Organization Policy on Protocol Record Retention Requirements for Investigators
• Policy 103.25 Organization Policy on Registration of Clinical Trials
• Policy 103.6(a) Organization Policy on Reporting
• Policy 103.6(b) Organization Policy on Reports of Unanticipated Problems Involving Risks to Participants or Others
• Policy No 103.7 Organization Policy on Investigator Non-Compliance
• Policy 107.2 Organization Policy on Consultants
• Policy 109.6(b) Organization Policy on Continuing Review of Approved Research
• Policy 111.5 Organization Policy on Scientific Review
• Policy 113.1 Organization Policy on Suspension or Termination of IRB Approved Research
• Policy No. D403 Organization Policy on Research Involving Children
• Policy No. FDA 312/812 Organization Policy on Clinical Investigations with FDA “Test Articles”
• Policy No. ORA.1 Organization Policy On Sponsor Responsibilities
• Policy No. PER 1 Organization Policy on Planned Emergency Research and Requirements for Waiver of Consent in Planned Emergency Research

May 2008

• Informed Consent of Subjects Who Do Not Speak English

• Conflict of Interest Statement in Human Subjects Consent Forms

March 2008

• Compliance Monitoring Program